News Releases

ST. LOUIS--(BUSINESS WIRE)--Dec. 12, 2013--
Mallinckrodt
(NYSE: MNK) today reported positive efficacy results in the Phase 3
clinical trial for MNK-155, an investigational extended-release oral
formulation of hydrocodone and acetaminophen studied for the management
of moderate to moderately severe acute pain where the use of an opioid
analgesic is appropriate. MNK-155 met the primary endpoint in this study.

Mallinckrodt also completed a series of other clinical trials evaluating
pharmacokinetics, safety and abuse liability of MNK-155. These data,
including the Phase 3 efficacy data, will be presented at a future
medical meeting and will be submitted to the U.S. Food and Drug
Administration (FDA) in a New Drug Application (NDA) for MNK-155. The
NDA is expected to be submitted in the second half of fiscal 2014.

“Despite the number of available pain medications, some patients
continue to experience unresolved pain. Our goal is to provide another
treatment option for the management of moderate to moderately severe
acute pain for patients and their physicians,” said Mario Saltarelli,
Chief Science Officer, Mallinckrodt. “We are encouraged by these
findings and look forward to submitting these results to the FDA as part
of our application.”

The Phase 3 efficacy study evaluated the efficacy and safety of MNK-155
in a post-surgical acute pain model. The primary endpoint was the summed
pain intensity difference (change in pain from baseline) over 48 hours
(SPID48) compared to placebo. The most common adverse events
associated with the use of MNK-155 were nausea (25%), vomiting,
dizziness, headache, constipation and somnolence (sleepiness).

Any statements contained in this communication that do not describe
historical facts may constitute forward-looking statements as that term
is defined in the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements include, but are not limited to, statements
about future financial condition and operating results, economic,
business, competitive and/or regulatory factors affecting our business.
Any forward-looking statements contained herein are based on our
management's current beliefs and expectations, but are subject to a
number of risks, uncertainties and changes in circumstances, which may
cause actual results or Company actions to differ materially from what
is expressed or implied by these statements. The factors that could
cause actual future results to differ materially from current
expectations include, but are not limited to, our ability to receive
procurement and production quotas granted by the U.S. Drug Enforcement
Administration, our ability to obtain and/or timely transport
molybdenum-99 to our technetium-99m generator production facilities,
customer concentration, cost-containment efforts of customers,
purchasing groups, third-party payors and governmental organizations,
our ability to successfully develop or commercialize new products, our
ability to protect intellectual property rights, competition, our
ability to integrate acquisitions of technology, products and
businesses, product liability losses and other litigation liability, the
reimbursement practices of a small number of large public or private
issuers, complex reporting and payment obligation under healthcare
rebate programs, changes in laws and regulations, conducting business
internationally, foreign exchange rates, material health, safety and
environmental liabilities, litigation and violations and information
technology infrastructure. These and other factors are identified and
described in more detail in the “Risk Factors” section of the Form 10
Registration Statement, as amended. We disclaim any obligation to update
these forward-looking statements other than as required by law.